2026 Predictions for Clinical Labs: AI, Audits, and Increased Enforcement
How clinical laboratories should prepare for the next wave of oversight in the new year
Legislation-lca
Subscribe today for access to
Articles and Reports
Chevron Doctrine’s Dismissal Has Yet to Upend Regulatory Environment
However, clinical laboratories may have more say in future laws and guidance thanks to 2024 decision
PAMA Cuts Loom and New Lab Reporting Deadline Nears, Both on January 1
However, a proposed bill called the RESULTS Act is racing to thwart the cuts to lab test reimbursement rates
Transitioning the Clinical Lab
What clinical laboratory professionals need to know about healthcare provision for transgender and nonbinary patients
LDTs Around the World
Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions
Special Analysis: Two Key Legislative Initiatives Labs Should Know About
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
AI Pilot Program Proposed to Detect Medicare Fraud
Program outlined in a recently introduced bill would test AI’s effectiveness in detecting suspect payments for diagnostic tests and DME.
Championing Change
How clinical laboratory professionals can advocate for legislative and regulatory improvements
Expert Q&A: What’s New with PAMA and SALSA?
Joyce Gresko, partner at Alston & Bird, discusses the latest on PAMA and what will likely need to happen for SALSA to pass in 2024.
The Future of Laboratory-Developed Tests
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.
AI in Healthcare: What Do Recent Developments Mean for Labs?
Genialis CEO and co-founder Rafael Rosengarten, PhD, discusses key 2023 AI developments and what they could mean for laboratories.
Eleven Things Labs Must Know to Comply with PAMA
An overview of PAMA and key aspects lab compliance officers should be aware of to help ensure compliance.
HHS Moves to Eliminate Controversial “SUNSET” Rule
On Oct. 28, the US Department of Health and Human Services served notice that it plans to repeal a controversial Trump rule.
